Topical copper ion treatments and methods of making topical copper ion treatments for use in various anatomical areas of the body

ABSTRACT

A topical copper ion treatment in basic form composes a copper ion-containing solution composed of a biocompatible solution containing copper ions obtained by leaching of the copper ions from copper metal into the solution. The copper ion-containing solution can be combined with various carriers to form various forms of the copper ion treatment including creams, gels, lotions, foams, pastes, tampons, solutions, suppositories, body wipes, wound dressings, skin patches, and suture material. A method of making the copper ion-containing solution involves placing solid copper metal in a quantity of a biocompatible solution and maintaining the solution at a specified temperature for a predetermined period of time during which copper ions each from the copper metal into the solution, and thereafter separating the solution from the solid copper metal

BACKGROUND OF THE INVENTION Field of the Invention

The invention pertains generally to topical treatments containing copperions and to methods of making topical treatments containing copper oilsfor use in treating conditions in various anatomical areas of the body.More particularly, the invention pertains to topical treatmentscontaining copper ions and to methods of making such topical treatmentswherein copper ions from copper metal are leached into a solution.

Brief Discussion of the Related Art

Many various abnormal body conditions are caused by harmful pathogens ormicrobes, examples of which include bacteria, fungi and viruses.Abnormal body conditions that arise in or affect the genital area inwomen typically affect the vagina and are commonly referred to as“vaginitis”. The term “vaginitis” encompasses infection and/orinflammation of the vagina caused by bacteria, fungi and/or viruses.Vaginitis may extend to the external female genital area, i.e. thevulva, in which case it is usually referred to as “vulvovaginitis”. Inaddition, bacterial, fungal and viral conditions that affect all or partof the genital area in women, i.e. vagina, vulva and/or surroundinganatomical area, may also affect all or part of the rectal (anal) area,i.e. the rectum (anal canal) and surrounding anatomical area. In men,infection and/or inflammation of bacterial, fungal and/or viral originsmay affect all or part of the rectal area and also all or part of thegenital area, i.e. the penis, scrotum and surrounding anatomical area.

Vaginitis that is bacterial in origin is commonly called “bacterialvaginosis”. Many different bacteria are responsible for bacterialvaginosis and some of these bacteria are the cause of sexuallytransmitted diseases in women and men. Examples of sexually transmittedbacterial diseases that affect the vagina and surrounding an areas aregonorrhea and chlamydia, which appear in the general population on awidespread basis. It is estimated by the Centers for Disease Control andPrevention (CDC) that more than 700,000 people annually in the U.S.alone acquire new gonorrhea infections. According to the CDC, over 1.3million chlamydia infections were recorded in the U.S. in 2010 alone. Inaddition, there are a large number of undiagnosed, untreated orunreported infections of gonorrhea and chlamydia because the diseasesmay be asymptomatic or present with only very mild symptoms. Oftentimes,gonorrhea and chlamydia occur together. Gonorrhea and chlamydia may alsoappear in the mouth, throat and rectum (anus) in men and women. If leftuntreated, gonorrhea and chlamydia can spread to the uterus and/orFallopian tubes and may cause pelvic inflammatory disease (PID)infertility, ectopic pregnancies, chronic pelvic pain and increased riskfor infection with the human immunodeficiency virus (HIV). Untreatedgonorrhea may also affect the blood, joints and heart valves. The usualtreatments for gonorrhea and chlamydia are appropriate antibiotics, buthistory has demonstrated that over time many bacterial diseases developa resistance to antibiotics. Indeed, according to the CDC, numerousantibiotics previously used to treat gonorrhea have lost theireffectiveness, and there is currently only one remaining drug, i.e. theinjectable antibiotic ceftriaxone, proven effective for treatinggonorrhea. There is great concern in the medical community that it isonly a matter of time before gonorrhea becomes resistant to this lastremaining drug. Other types of pathogens and microbes, such as thebacteria streptococcus and staphylococcus and the parasitic protozoantrichomonas, may also affect the vagina and surrounding anatomical areasresulting in abnormal biological conditions. As with gonorrhea,staphylococcus infections are especially problematic because certainstrains of the bacteria have become antibiotic resistant. Infections inthe vagina may spread to the uterus, resulting in PID which is often avery painful and serious condition with potentially harmful andpermanent complications.

In addition to being susceptible to abnormal body conditions caused bybacteria, the vagina and surrounding anatomical areas are susceptible tovarious abnormal body conditions caused by viruses and fungi. Viraldiseases that arise in or affect the vagina and surrounding anatomicalareas include herpes (Types I and II), human papilloma virus (HPV) andHIV, all of which are sexually transmittable. Herpes, HPV and HIV canalso be found in the areas of the mouth, skin and rectum (anus). Fungaldiseases that arise in or affect the vagina include yeast infections,particularly candida, and thrush. Fungi are also responsible forabnormal biological conditions in other areas of the body such as themouth (thrush), feet, skin and nails. There is no cure for herpes andHIV. Anti-viral drugs are available to alleviate herpes symptoms andsuppress the herpes virus so that active infections recur lessfrequently and are of shorter duration, but these drugs are associatedwith significant side effects. Infection with HPV is usually treatedwith topical medications, oral medications and/or surgical removal ofwarts. Complications of HPV infection include increased risk forcervical, rectal and vulvar cancers. Available treatments for HIV aredesigned to suppress the virus and boost the immune system in hope ofavoiding opportunistic infections and delaying or preventing the onsetof full-blown acquired immune deficiency syndrome (AIDS). In recentyears, it was hoped that a vaginal microbicide gel called PRO 2000 wouldbe effective at reducing HIV infection when used shortly before sexualintercourse, but unfortunately the compound was found to be ineffectivein a large scale clinical trial. Topical and oral medications areavailable to treat yeast and other fungal infections but are limited ineffectiveness such that fungal infections are often not eradicated andthus reoccur. The vast majority of abnormal body conditions causedbacteria, viruses and fungi that affect the genital and/or rectal areasin women also affect the genital and/or rectal areas in men.

In addition to conditions caused by harmful pathogens or microbes,hemorrhoids are another abnormal body condition that affects the rectum(anus) in men and women and may cause rectal pain, swelling, discomfortand/or itching. Conventional treatments for hemorrhoids include topicalmedications and surgery. In addition to harmful microbes and pathogens,sperm are microbes that appear in the vagina after intercourse. Numerousspermicidal contraceptive compounds are available for introduction inthe vagina. Typically, these must be introduced in the vagina veryshortly before intercourse and are therefore oftentimes inconvenient.When intercourse takes place without contraception and there is concernfor an unwanted pregnancy, drugs known as the “morning after pill” or“emergency contraceptives” are sometimes prescribed to preventpregnancy, but these drugs are not 100% effective and may haveundesirable side effects.

Abnormal body conditions of bacterial, viral and fungal origins commonlyarise in dermatological areas of the body, i.e. skin and nails. The skinand soft tissue are common sites for infections caused by variousbacteria including staphylococcus, enterobacter, pseudomonas, andstreptococcus. Oftentimes, infections develop on the skin at the site ofa cut, scratch, abrasion, burn, splinter, boil, pimple, blister, insectbite or other wound or trauma that damages or breaks the skin orprovides a point of entry for bacteria and/or other harmful organisms.Viruses such as herpes, shingles and HPV are also the cause of abnormalbody conditions on the skin. In particular, herpes causes cold sores(fever blisters), shingles causes painful eruptions, and HPV causeswarts on the skin. Other organisms also cause warts on the skin. Theskin is susceptible to various fungal conditions, such as “athlete'sfoot” which commonly occurs on the feet and rashes such as ringworm.Infections of the nails, particularly fungal infections of the toenails,are also a common and tenacious problem. The skin is further susceptibleto various body conditions resulting from aging, environmental factorsand various external and internal causes, such conditions includingsun/wind damage, dry skin, age spots, pigmentation, scarring, blisters,boils, cysts, pimples, cuts, scratches, burns, abrasions, splinters,insect bites and stings, animal bites and scratches, ulcers, loss ofelasticity or collagen that manifests as winkles and sagging skin, acne,and many types of rashes, such as measles, chicken pox, eczema,psoriasis, impetigo and rosacea, due to various underlying external andinternal causes. Various topical and oral prescription andnon-prescription medications and products are available to treat theforegoing skin conditions. The skin is also a carrier for bacteria,viruses and fungi, seeing as how the skin regularly comes in contactwith a plethora of pathogens and microbes. Consequently, many productssuch as sanitizing hand and body lotions and wipes are availablecommercially for the purpose of reducing germs on the skin.

The oral-respiratory-otic areas of the body, i.e. mouth, throat, nose,sinuses and ears are also common sites for abnormal body conditions dueto the aforementioned pathogens and microbes. In addition, variousallergies cause undesirable body conditions that impact theoral-respiratory-otic areas of the body, particularly the throat, noseand sinuses. Asthma is a chronic inflammatory disease of the airwaysresponsible for undesirable conditions. Bacteria, viruses, fungi,allergies and/or asthma are responsible for many unwanted symptoms thatappear in the oral-respiratory-otic areas of the body including sorethroat, tonsillitis, colds, bronchitis, sinusitis, rhinosinusitis,wheezing, ear infections, earache, pressure in the ears, cold sore,mouth ulcers, canker sores, cough, hoarseness or laryngitis, congestion,runny nose, sneezing, sore gums, periodontal disease, tooth decay andhalitosis (bad breath). A vast array of prescription andnon-prescription drugs and products are commercially available to treatoral-respiratory-otic conditions.

The prescription drugs and even many of the non-prescription drugs orproducts used to treat the numerous body conditions described above havemany drawbacks including undesirable or potentially harmful sideeffects, high risk of harm in the event of overdose or improper use,high cost, limited effectiveness, the need for close medical monitoring,and inconvenience. Moreover, there is presently no single compound orproduct to treat a wide range of body conditions affecting thegenital-rectal areas that include the vagina, rectum (anus), andsurrounding anatomical areas, oral-respiratory-otic areas that includethe mouth, throat, airway, nose, sinuses and ears, and thedermatological areas that include the skin and nails, much less anon-pharmaceutical topical treatment that is safe, cost-effective, easyand convenient to use, and capable of being embodied in different formsdepending on the intended anatomical area or areas of use.

It has previously been established that copper possesses properties bywhich it is capable of killing, neutralizing and preventing the growthof human pathogens. It is known that many bacteria identified as humanpathogens cannot survive on surfaces of copper metal U.S. Pat. No.8,135,466 B2 to Fuller et al discloses a joint prosthesis having animplant body with an external surface containing an antimicrobial metalwhere the antimicrobial metal may be copper. U.S. Patent ApplicationPublications No. US 2012/0071807 A1 and No. US 2012/0089068 A1 toMcClure, Jr. disclose wound dressings containing a metal-basedantimicrobial agent where the metal-based antimicrobial agent may be amixture of silver ions and copper ions. Devices having an externalsurface of copper metal for insertion in the vagina to treat abnormalbiological conditions have been proposed by Applicants in U.S. patentapplication Ser. No. 12/157,823 filed Jun. 13, 2006 (abandoned), Ser.No. 13/317,230 filed Oct. 12, 2011, and Ser. No. 13/464,005 filed May 4,2012, the entire disclosures of which are incorporated herein byreference.

Topical substances containing particles of copper or its alloys havebeen proposed for health support uses. A product called “MesoCopper®”sold by Purist Colloids, Inc. is a colloidal copper solution containingnano particles of copper for use on the skin to minimum the appearanceof tine lines and wrinkles. Another version of the product is sold as aningestible mineral supplement. Copper peptides for use on the skin arealso commercially available and these require peptides, i.e. smallfragments of protein that have an affinity for copper to which they bindvery tightly, U.S. Pat. No. 7,716,915 B2 to Morariu discloses a topicalcomposition containing, at a minimum, a lipoic acid, a carnitine and acarnosine, where the carnosine may be chelated to zinc or copper ions.The intended use for the topical composition is to improve theappearance of aged skin, U.S. Patent Application Publication No.US2008/0195033 A1 to Eagleson et al discloses use of a metal substanceto treat diseases in the body. The metal substance is primarily acolloidal suspension and delivery of the substance to the body mayrequire the use of electricity. Prior to the present invention, it hasnot been recognized to provide a simple solution containing copper ionsfor use as a topical treatment to be applied directly to anatomicaltissue to treat body conditions and/or for use in conjunction withvarious carriers including creams, gels, lotions, foams, pastes, othersolutions, suppositories, tampons, body wipes, wound dressings, skinpatches and suture material to form topical treatments in which thecarriers facilitate delivery of the copper ions to contact anatomicaltissue depending on the anatomical area or areas of use on the body.

SUMMARY OF THE INVENTION

According to an aspect of the invention, a topical copper ion treatmentis prepared by a process whereby copper ions from copper metal leachinto a biocompatible solution. The copper metal in solid form is placedinto the solution in a sealed vessel, and the sealed vessel is placed inan oven to heat or maintain the solution at a temperature equal orsubstantially equal to 37° Celsius for a predetermined period of timeduring which copper ions leach from the copper metal into the solution.After the period of time has expired, the solution is separated from thecopper metal and constitutes a copper ion-containing solution that canbe used as a copper ion treatment for topical application to anatomicaltissue in various areas of the body to treat various body conditions.Preferably, the biocompatible solution is a saline solution and thecopper metal is pure copper. A copper ion-containing solution obtainedin accordance with a preferred process results in en amount of copperions equal or substantially equal to 46 mg present in 7.44 ounces of thecopper ion-containing solution.

The copper ion-containing solution can be combined with various carriersto facilitate application or delivery of the copper ion-containingsolution to anatomical tissue in accordance with the anatomical area orareas of use. Suitable carriers include creams, lotions, gels, foams,pastes, other solutions, tampons, suppositories, body wipes, wounddressings, skin patches and suture material to obtain other forms ofcopper ion treatments. Various devices such as containers, bottles andtubes can be used to dispense the copper ion treatments in a manner bestsuited for the form of copper ion treatment and/or the intendedanatomical area or areas of use. The copper ion treatments areparticularly advantageous for use on anatomical tissue of thegenital-rectal areas, the oral-respiratory-otic areas and thedermatological areas of the body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a bottle containing a copper ion treatment andhaving a spray pump nozzle for dispensing the copper ion treatment.

FIG. 2 is a side view of a bottle containing a copper on treatment andhaving a spray pump nozzle with an elongate extension for dispensing thecopper ion treatment.

FIG. 3 is a side view of a bottle containing a copper ion treatmentwherein the bottle is squeezable to dispense the copper ion treatmentfrom a dropper on the bottle.

FIG. 4 is a side view of a bottle containing a copper ion treatment andhaving a brush for applying the copper ion treatment to an tissue.

FIG. 5 is a side view of a tube containing a copper ion treatmentwherein the tube is squeezable to dispense the copper ion treatment.

FIG. 6 is a side view of an alternative battle that is squeezable todispense a copper ion treatment and showing the bottle in a closedcondition.

FIG. 7 is a side view of the bottle of FIG. 6 showing the bottle in anopen condition.

FIG. 8 is a side view of a bottle containing a copper ion treatment andhaving a pump nozzle for dispensing the copper ion treatment in the formof foam.

FIG. 9 is a side view of an applicator for delivering a copper iontreatment to the vagina.

FIG. 10 is a side view of the applicator of FIG. 9 showing use of theapplicator in conjunction with the tube of FIG. 5.

FIG. 11 is a side view of an alternative applicator for applying copperion treatment onto anatomical tissue.

FIG. 12 is a side view of a tampon having a tampon body used as acarrier to deliver a copper ion treatment to the vagina.

FIG. 13 is a broken front view of a plurality of suppositoriescontaining a copper on treatment, the suppositories being insertable inthe vagina or rectum to deliver the copper ion treatment to the vaginaor rectum.

FIG. 14 is a side view showing a suppository of FIG. 13 being removedfrom its package.

FIG. 15 is a side view of an applicator for delivering the suppositoriesof FIG. 13 to the vagina or rectum.

FIG. 16 is a front view of a package containing a body wipe carrying acopper ion treatment and showing the package partially open to removethe body wipe therefrom.

FIG. 17 is a perspective view of a wound dressing supplied with a copperion treatment.

FIG. 18 is a plan view of a skin patch carrying a copper ion treatment.

FIG. 19 is a perspective view of sutures created in anatomical tissueusing suture material carrying a copper ion treatment.

DETAILED DESCRIPTION OF THE INVENTION

A solution maintaining copper ions, i.e. copper ion-containing solution,for use as a topical treatment containing copper ions, i.e. topicalcopper ion treatment, to treat body conditions is produced according toa process or method by which copper ions from copper metal are leachedinto an appropriate biocompatible solution. As used herein, “coppermetal” means pure copper (99.5% or greater copper after processing) andcopper alloys such as brasses, bronzes, copper-nickels andcopper-nickel-zincs. Preferably, pure copper is used as the coppermetal. Example 1 describes the steps involved in producing an amount ofcopper ion-containing solution equal or substantially equal to 7.44ounces.

EXAMPLE 1

7.44 ounces of biocompatible saline solution buffered with acetic acidand sodium acetate to a pH of 5 (±0.4) is placed in a container orvessel with a tight, removable lid to minimize evaporation. Thecontainer is placed in an incubator or oven at a temperature of 37°Celsius (±1° C.). When the saline solution has reached 37° Celsius, 102grams of pure copper metal in solid form is placed in the heatedsolution within the container, and the container with the tight lidthereon is placed in the incubator at 37° Celsius for 24 hours. Duringthe 24 hour period, copper ions from the copper metal leach into thesolution. At the end of the 24 hour period, the container is removedfrom the incubator and the copper metal is removed or separated from thesolution. The amount of solution remaining after removal or separationof the cooper metal therefrom constitutes the copper ion-containingsolution and should be essentially 7.44 ounces with minimal evaporation.The copper ion-containing solution produced according to this processcontains copper ions an amount equal or substantially equal to 46milligrams when analyzed for copper content by inductively coupledplasma/optical emission spectroscopy (ICP/OES). The copperion-containing solution is stored at room temperature and is ready foruse it this form as a topical copper ion treatment to be applied toanatomical tissue to treat body conditions. In addition, the copperion-containing solution is ready for use in conjunction with variouscarriers including creams, gels, lotions, foams, pastes, othersolutions, suppositories, tampons, body wipes, wound dressings, skinpatches and suture materials to form topical copper ion treatments inwhich the carriers facilitate delivery of the copper, ion treatments tocontact anatomical tissue to treat body conditions.

The solid pure copper metal in Example 1 may be in the form of one ormore sheets of pure copper metal, typically in the range of 0.03 to 0.06inch thick, of appropriate length and width to provide the 102 grams ofpure copper metal. In practice, the process described in Example 1 hasbeen carried out using as the copper metal four vaginal therapeuticdevices made of pure copper in accordance with Applicants' prior patentapplication Ser. No. 13/464,005 previously incorporated herein byreference in its entirety. In this case, each vaginal therapeutic deviceused was 3.25 inches long by 0.750 inch wide with a wall thickness of0.031 inch providing 25.5 grams of pure copper. The biocompatible salinesolution used in the process described in Example 1 is commerciallyavailable from B. Braun Medical. As an alternative to the biocompatiblesaline, vaginal simulating fluid (VSF) buffered with acetic acid to a pHof 5 (±0.4) can be used as the biocompatible solution, but will produceless leaching of copper ions from copper metal over the 24 hour period.The VSF can be prepared in accordance with published literature, e.g.Owen, D. H., Katz, D. F., “A Vaginal Fluid Simulant”, Contraception,pages 94-95 (1999). The process described in Example 1 can be modifiedto eliminate the step of heating the solution prior to placement of thecopper metal therein. In the latter case, the copper metal and unheatedsolution are placed in the container, the container with the tight lidthereon is placed in the incubator at 37° Celsius and, once the solutionhas reached 37° Celsius, the container with the heated solution andcopper metal therein is allowed to remain in the oven for 24 hours. Thecopper metal can be removed or separated from the solution in variousways, such as by lifting the metal out of the solution or pouring thesolution alone into another container. Of course, the quantities ofbiocompatible saline and solid copper mental used in Example 1 can beproportionately increased to produce a greater amount of copperion-containing solution with each process.

The copper ion-containing solution is believed to have the greatesteffectiveness for treating a wide range of body conditions when thesolution contains the amount of copper ions leached into the saline fromthe copper metal over a 24 hour period as described in Example 1.However, it should be appreciated that the process described in Example1 can be modified to obtain lower copper ion concentrations by adjustingthe length of time that the container containing the heated saline andcopper metal is allowed to remain in the incubator or oven as explainedbelow in Examples 2, 3 and 4.

EXAMPLE 2

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the oven at 37° C. for one hour toobtain a copper ion-containing solution that contains an amount ofcopper ions equal or substantially equal to 8.8 mg.

EXAMPLE 3

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the oven at 37° C. for eight hoursto obtain a copper ion-containing solution that contains en amount ofcopper ions equal or substantially equal to 22 mg.

EXAMPLE 4

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the oven at 37° C. for 72 hours toobtain a copper ion-containing solution that contains an amount ofcopper ions equal or substantially equal to 35 mg.

The copper ion-containing solution in its original form, i.e. at the endof the processes of Examples 1-4, can be applied directly to anatomicaltissue in various anatomical areas of the body as a copper ion treatmentto treat various body conditions. Many types of containers or bottlescan be used to hold a quantity of the copper ion-containing solution andto dispense or apply the copper ion-containing solution to anatomicaltissue in accordance with the intended anatomical area or areas of use.The copper ion-containing solution may also be used in conjunction withvarious carriers including creams, lotions, gels, foams, pastes, othersolutions, tampons, suppositories, body wipes, wound dressings such asband aids and pads, skin patches and suture material to form copper iontreatments that facilitate delivery or application of the copperion-containing solution, and therefore the copper ions, to anatomicaltissue. Creams, lotions, gels, foams a pastes may be used when it isadvantageous to alter the consistency of the copper toil-containingsolution from its original form to obtain a thicker copper ion treatmentto facilitate its delivery or application to anatomical tissue. As aresult of the copper ions contacting anatomical tissue when the copperion treatments are applied thereto, local and systemic therapeuticeffects are realized including antibacterial, antimicrobial, antiseptic,antifungal, antiviral, anti-pathogenic, anti-inflammatory, spermicidalneutralization of free radicals, promotion of healing and tissue repair,prevention of biofilm, and immune-boosting effects. In particular, theseeffects are realized when the copper ion treatments are used onanatomical tissue in the genital-rectal areas, the oral-respiratory-oticareas and the dermatological areas of the body since the anatomicaltissue in these areas is favorable for local and systemic delivery ofdrugs and medicaments.

In accordance with an aspect of the present invention the copperion-containing solution is combined with an appropriate topical creambase to form a copper ion-containing cream, i.e. copper ion cream inwhich the amount of copper ion-containing solution is preferably in therange of 5% to 30% by weight of the total weight of the copper ioncream. Examples 5, 6, 7 and 8 pertain to copper ion creams made inaccordance with this aspect of the invention using the copperion-containing solution of Example 1.

EXAMPLE 5

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 5 percent of the totalweight of the copper ion cream.

EXAMPLE 6

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 10 percent of the totalweight of the copper ion cream.

EXAMPLE 7

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion containing solution constitutes 20 percent of the totalweight of the copper ion cream.

EXAMPLE 8

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 30 percent of the totalweight of the copper ion cream.

Various topical cream blues can be used as the carrier for the copperion-containing solution in order to form the copper ion creams ofExamples 5, 6, 7 and 8. One suitable topical cream base that can be usedis VersaBase® cream made by Professional Compounding Centers of America(PCCA) of Houston, Tex. Another suitable topical cream base that can beused in the copper ion creams is Vanicream® made by PharmaceuticalSpecialties, Inc. of Rochester, Minn. The copper ion creams areeffective against the body conditions being treated when the only activeingredient in the copper ion creams directed at the underlying conditionis the copper ion-containing solution. However, the copper ion creamscould contain other ingredients added to the topical meant base that arenot active ingredients with respect to the underlying condition beingtreated such as preservatives, penetrating additives, bioadhesives andstability aids. Preferably, a total weight of at least 70 grams, morepreferably 80 grams, of the copper on creams in the various strengths,i.e. 5 percent, 10 percent, 20 percent and 30 percent of copperion-containing solution relative to the total weight of the copper ioncream, will be provided for use in containers, bottles, or tubes fromwhich the copper ion creams can be dispensed. It should be appreciatedthat copper ion creams can be made using the alternative copperion-containing solutions described above.

According to a further aspect of the present invention, a topical copperion treatment in the form of a copper ion-containing gel, i.e. copperion gel, is composed of the copper ion-containing solution and asuitable topical gel base as illustrated below by Examples 9, 10, 11 and12, which utilize the copper ion-containing solution of Example 1. Theamount of the copper ion-containing solution in the copper ion gel ispreferably in the range of 5% to 30% by weight of the total weight ofthe copper ion gel.

EXAMPLE 9

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 5 percent of the total weightof the copper ion gel.

EXAMPLE 10

An appropriate amount of copper ion-containing solution is combined withbiocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 10 percent of the totalweight of the copper ion gel.

EXAMPLE 11

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 20 percent of the totalweight of the per ion gel.

EXAMPLE 12

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 30 percent of the totalweight of the copper ion gel.

Various topical gel bases can be used as a carrier for the copperion-containing solution in order to form the copper ion gels. An exampleof a suitable topical gel base that can be used in Examples 9-12 isVersaBase® gel made by PCCA. As explained above for the copper oncreams, the copper ion gels will be effective when the only activeingredient in the copper ion gels is the copper ion-containing solution,but other ingredients that are inactive with respect to the underlyingcondition being treated can be added to the topical cream gels.Preferably, a total weight of at least 70 grams, more preferably 80grams, of the copper ion gels in the various strengths, i.e. 5 percent,10 percent, 20 percent and 30 percent of copper ion-containing solutionrelative to the total weight of the copper on gel, is provided for usein containers, bottles or tubes from which the copper ion gels can bedispensed. Also, copper ion gels can be made using the alternativecopper ion-containing solutions. Copper ion gels can be made having athin, fluidic consistency, and such gels may be used as copper ionserums.

A topical copper ion treatment in the form of a copper ion-containinglotion, i.e. copper ion lotion, according to an additional aspect of theinvention is composed of the copper ion-containing solution and asuitable topical lotion base as represented by Examples 13, 14, 15 and16. Examples 13-16 employ the copper ion-containing solution of Example1, but copper ion lotions could be made using the alternative copperion-containing solutions. The amount of the copper ion-containingsolution in the copper ion lotion is preferably in the range of 5% to30% by weight of the total weight of the copper ion lotion. Copper iongels can be made having a thin fluidic consistency, and such gels may beused as copper ion serums.

EXAMPLE 13

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 5 percent of the totalweight of the copper ion lotion.

EXAMPLE 14

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 10 percent of the totalweight of the copper ion lotion.

EXAMPLE 15

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 20 percent of the totalweight of the copper ion lotion.

EXAMPLE 16

An appropriate amount of copper ion-containing solution is combined withbiocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 30 percent of the totalweight of the copper ion lotion.

Various topical lotion bases can be used as a carrier for the copperion-containing solution in the copper ion lotions of Examples 13-16. Onesuitable topical lotion base that can be used is VersaBase® lotion madeby PCCA. As explained above for the copper ion creams and gels, thecopper ion lotions will be effective against the body conditions beingtreated when the only active ingredient in the copper ion lotions is thecopper ion-containing solution, but other inactive ingredients could beadded to the topical lotion base. Preferably, a total weight of at least70 grams, more preferably 80 grams, of the copper ion lotions in thevarious strengths, i.e. 5 percent, 10 percent, 20 percent and 30 percentof copper ion-containing solution relative to the total weight of thecopper ion lotion, will be provided for use in containers, bottles ortubes from which the copper ion lotions can be dispensed.

According to another aspect of the present invention, a topical copperion treatment in the form of a copper ion-containing foam, i.e. copperion foam, is composed of the copper ion-containing solution and asuitable foam base. Examples 17, 18, 19 and 20 set forth below pertainto copper on foams or foamable solutions made in accordance with thisaspect of the invention using the copper ion-containing solution ofExample 1, however copper ion foams or foamable solutions can be madeusing the alternative copper ion-containing solutions. The amount of thecopper ion-containing solution in the copper ion foam or foamablesolution is preferably in the range of 5% to 30% by weight of the totalweight of the copper ion foam or foamable solution.

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 5percent of the total weight of the copper ion foam or foamable solution.

EXAMPLE 18

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 10percent of the total weight of the copper ion foam or foamable solution.

EXAMPLE 19

An appropriate amount of copper ion-containing solution is combined witha biocompatible to foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 20percent of the total weight of the copper ion foam or foamable solution.

EXAMPLE 20

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 30percent of the total weight of the copper ion foam or foamable solution.

Various topical foam bases can be used as a caller for the copperion-containing solution in order to form the copper ion foams orfoamable solutions. Depending on the foam base used in Examples 17-20,the combination of foam base and copper ion-containing solution may bein the form of a foam. Alternatively, some foam bases that may be usedwill result in a foamable solution when combined with the copperion-containing solution, and the foamable solutions will typicallyrequire an appropriate dispenser to create the actual foam. An exampleof a suitable topical foam base that can be used is VersaBase® foam madeby PCCA. When using VersaBase® as the foam base in Examples 17-20, afoamable solution is obtained and requires a foam dispenser to createthe foam. As explained above for the copper ion creams, gels andlotions, the copper ion foams will be effective against the bodyconditions being treated with the only active ingredient therein beingthe copper ion-containing solution. However, other ingredients that areinactive with respect to the condition being treated can be added to thetopical foam base. It is preferred that a total weight of at least 70grams, more preferably 80 grams, of the copper ion foams or foamablesolutions in the various strengths, i.e. 5 percent, 10 percent, 20percent and 30 percent of copper ion-containing solution relative to thetotal weight of the copper ion foam or foamable solution, be provided indispensers from which the copper ion foams can be dispensed.

According to a further aspect of the invention, a topical copper iontreatment in the form of a copper ion-containing paste, i.e. copper ionpaste, is composed of the copper ion-containing solution and a suitablepaste base. Example 21 set forth below pertains to a copper iontoothpaste made in accordance with this aspect of the invention usingthe copper ion-containing solution of Example 1, but copper ion pastescan also be made using the alterative copper ion-containing solutions.The amount of the copper ion-containing solution in the copper ionpastes is preferably in the range of 5% to 30% by weight of the totalweight of the copper on paste.

EXAMPLE 21

An appropriate amount of copper ion-containing solution is combined witha toothpaste base material to form a copper on toothpaste in which thecopper ion-containing solution constitutes in the range of 5 percent to30 percent of the total weight of the copper on toothpaste.

The toothpaste base material used in Example 21 can be a commerciallyavailable toothpaste including any of the toothpastes marketed and soldunder the major brand names. A toothpaste made in accordance withExample 21 is advantageous for treating bad breath, sore gums, gumdisease and tooth decay when used on a daily basis in place of aperson's regular toothpaste.

According to a further aspect of the invention, the copperion-containing solution can be combined with various base solutions toform alternative copper ion solutions. Example 22 set forth belowpertains to a copper ion mouthwash made in accordance with this aspectof the invention using the copper ion-containing solution of Example 1,but copper ion solutions can also be made using the alternative copperion-containing solutions of Examples 2-4. The amount of copperion-containing solution in the alternative copper ion solution ispreferably in the range of 5% to 30% by weight of the total weight ofthe copper ion solution.

EXAMPLE 22

An appropriate amount of copper ion-containing solution is combined witha mouthwash base solution to form a copper ion mouthwash in which thecopper ion-containing solution constitutes in the range of 5 percent to30 percent of the total weight of the copper ion solution.

The mouthwash base solution used in Example 22 can be a commerciallyavailable mouthwash including any of the mouthwashes marketed and soldunder the major brand names. A mouthwash made in accordance with Example22 is advantageous for treating bad breath, sore gums, periodontaldisease and tooth decay when used on a daily basis.

The examples described above pertaining to carriers in the nature oflotions, gels, foams and other solutions are particularly well suitedfor creating copper ion treatments in the nature of copper ion soaps byusing as carriers lotion, gel, foam or other solution bases containing asoap component. The copper ion soaps could be designed for use as bodysoaps or as dish soaps.

FIG. 1 depicts a device 10 useful for dispensing the copper iontreatments, particularly the copper ion-containing solutions in theiroriginal form, e.g. the form resulting from Examples 1-4, and the copperion lotions. The device 10 comprises a container or bottle 12 forholding the copper ion-containing solution and having a spray pumpnozzle 14 with an outlet orifice 16. The spray pump nozzle 14 isresiliently biased, typically by a spring, in an upward direction awayfrom the container 12 but is depressible in a downward direction towardthe container 12 to effect the spray pump action. Each time the spraypump nozzle is manually depressed the full mount, typically using afinger of the hard holding the container, a predictable amount of copperion-containing solution is discharged in the form of a spray or streamfrom the outlet orifice 16. The container 12 may include a removableprotective cover 18 for being disposed over the spray pump nozzle 14between uses. In use, the outlet orifice 16 is placed in line withanatomical tissue to be treated at a close enough distance that thetissue is within the range of the spray or stream dispensed from theoutlet orifice. The spray pump nozzle 14 is then depressed the fullamount using a finger, causing the predictable amount of copperion-containing solution to be delivered or sprayed onto the anatomicaltissue. The spray pump nozzle 14 can, of course, be depressed multipletimes to deliver multiple sprays or streams of the copper ion-containingsolution to the tissue. The device 10 would also be adapted to dispensethe copper ion lotions in a similar manner, although in such case thecopper ion lotions would typically be dispensed in the form of a ribbon,mass or stream of material. In the latter case, the copper ion lotionscould be dispensed directly on the tissue to be treated, or on the palmor fingers of a hand which is then used to apply the lotions on thetissue to be treated. The copper ion lotions may be best suited for useon the skin, on the external genital and rectal areas, and in thevagina.

Another device 20 useful for dispensing the copper ion treatments,particularly the copper ion-containing solution in its original form, isshown in FIG. 2. The device 20 is similar to the devices 10 andcomprises a container or bottle 22 having a spray pump nozzle 24 with anoutlet orifice 26. The device 20, however, further includes an elongatehollow extension 28 attached to the spray pump nozzle 24. The extension28 has a first end coupled with the outlet orifice 26 of the spray pumpnozzle 24 and has an opposed second end with a wider end surface havinga discharge opening 29. Preferably, a plurality of discharge openings 29are provided along the wider end surface as shown in dotted lines inFIG. 2 to obtain a wider spray pattern as indicated by dotted lines.Each time the spray pump nozzle 24 is manually depressed the fullamount, a predictable amount of copper ion treatment is released inspray form from the discharge openings 29 at the end of the extension28. The wider end surface and plurality of discharge openings at thesecond end of the extension provides a wider spray pattern than thedevice 10. The device 20 could be designed without the spray pumpnozzles with the container 22 being squeezable to force the copper iontreatment to be discharged from the discharge opening(s) 29. Theextension 28 may be selectively detachable/attachable to the spray pumpnozzle 24 for ease of storage of the device 20. The device 20 mayinclude a removable protective cover (not shown) for being placed overthe nozzle 24 between uses. The device 20 is particularly useful as anatomizer for dispensing the copper ion treatments to contact anatomicaltissue deeper within the mouth, throat and airway.

The device 30 depicted in FIG. 3 is also useful for dispensing thecopper ion treatments, particularly the copper ion-containing solutionin its original form. The device 30 comprises a squeezable container orbottle 32 for holding the copper ion treatment and having a tapereddropper or extension 34 with an outlet orifice 36 attached to a cap onthe container 32. In use, the container 32 is positioned so that theoutlet orifice 36, which is located at the tip of the dropper, facesanatomical tissue to be treated. The container 32 is then squeezed withthe fingers and, in response to such finger pressure, individual dropsof a predictable amount of copper ion treatment are released from theoutlet orifice 36. Alternatively, the extension 34 can be designed todischarge the copper ion treatment in the form of a spray as shown indotted lines in FIG. 3, which would be particularly useful as anasal/ear spray. The tapered configuration of the dropper/extension 34facilitates its placement in the nostril (nasal cavity) and ear (earcanal). The container 32 may include a removable protective cover 38 forbeing disposed over the dropper 34 between uses. The device 30 isparticularly useful for dispensing the copper ion treatments to contactanatomical tissue within the nose (nostrils), ears (ear canal), skin andnails.

An additional device 40 for dispensing the copper ion treatments isshown in FIG. 4. The device 40 comprises a container or bottler 42 forholding the copper ion treatment and having a removable cap 44 with abrush 45 attached to an underside of the cap. Typically, the cap 44 willbe screwed onto a neck of the container 42. When the cap 44 is disposedon the container 42, the brush 46 extends into the container and isdisposed within the copper ion treatment 43. Upon removal of the cap 44from the container 42, the cap 44 may be manipulated using the fingersand hand to contact anatomical tissue to be treated with the brush 45 inorder to deposit the copper ion treatment from the brush 45 onto theanatomical tissue. The device 40 would be particularly useful forapplying the copper on treatments on the skin and nails. The brush 45could be eliminated from the cap 44, in which case the device 40, ifsized appropriately, would be advantageous for holding a copper onsolution such as a copper ion mouthwash.

The device 50 illustrated in FIG. 6 is particularly useful fordispensing the copper on treatments formed as creams, lotions, gels andpastes. The device. 50 comprises a container 52 in the form of asqueezable tube for holding the copper ion treatment and having aremovable cap 54 disposed on an open end or neck 56 of the tube.Typically the cap 54 will be threaded onto an external thread 55 on theneck 56 of the tube. The cap 54 may optionally have a piercing formation57 that may be used to puncture an optional seal covering the open neck56 prior to the first use. Upon removal of the cap 54, the piercingformation 57 is placed against the seal, and the cap 54 is pushed in thedirection of the tube 52 to puncture the seal. Once the seal ispenetrated, the tube 52 can be squeezed, preferably from the bottom ofthe tube working upward, causing the copper ion treatment to bedispensed from the open neck 56 of the tube. The device 50 isparticularly well suited for dispensing the copper ion treatments ontothe fingers or palm of a hand that is then used to apply the treatmentsto anatomical tissue, particularly the tissue of the skin and theexternal genital and rectal areas. However, the copper ion treatmentscould be squeezed directly on the anatomical tissue to be treated. Inaddition, when the copper ion treatment is in a paste or other suitableform for use as a toothpaste, the device 50 is particularly well suitedfor dispensing the copper ion treatment onto a tooth brush in aconventional manner. As explained further below, the device 50 isparticularly well suited for use with a vaginal applicator.

FIGS. 6 and 7 depict an additional device 60 useful for dispensing thecopper ion treatments. The device 60 is particularly advantageous fordispensing copper ion lotions. The device 60 comprises a container orbottle 62 for holding the copper ion treatment and having a cap 64disposed on an open end or neck of the bottle. The cap 64 could beremovable or non-removable. The top surface of the cap 64 is formed by apivotable member or disc 65 having an outlet orifice 66 along a sideedge thereof. FIG. 6 depicts the cap 64 in its closed condition whereinthe pivotable member 65 is in a horizontal position relative to the cap64 and the outlet orifice 66 is disposed within the cap 64 and is notexposed. When the pivotable member 65 is depressed downwardly toward thecontainer 62 at a location opposite the outlet orifice 66 as shown bythe arrow in FIG. 7, the cap 64 will assume the open condition shown inFIG. 7 wherein the pivotable member 65 is disposed at an angle relativeto the cap 64 and the outlet orifice 66 is in an exposed positionlocated slightly above the cap 64. In use, the pivotable member 65 wouldbe depressed using pressure applied with one or more fingers of thehand. With the cap 64 in the open condition as shown in FIG. 7, thecontainer 62 can be squeezed manually to dispense the copper iontreatment therein from the outlet orifice 66. The cap 64 is returned tothe closed position by pressing downwardly on the pivotable member 66 ata location adjacent the outlet orifice. The device 60 is advantageousfor dispensing the copper ion treatments onto the palm of the hand orfingers used to apply the treatment to anatomical tissue to be treated,but the device 60 could be used to dispense the copper ion treatmentsdirectly on the anatomical tissue to be treated.

The device 70 shown in FIG. 8 is an example of a device that can be usedto dispense the copper on treatment in the form of a copper ion foam.The device 70 comprises a container 72 for holding the copper ion foamor foamable solution and having a resiliently biased foam pump dispenser74 with an outlet orifice 76. When the foam pump dispenser 74 isdepressed the full amount in a manner similar to the device 10, apredictable amount of the copper ion foam is discharged through theoutlet orifice 76. If necessary, the device 70 may include a mechanismfor creating foam as the copper ion treatment is discharged therefrom.The device 70 may have a removable protective cover 78 for beingdisposed over the foam pump dispenser 74 between uses. The device 70could also be adapted to dispense copper ion lotions and gels.

FIG. 9 depicts a vaginal applicator 81 useful for delivering the copperion treatments to the vagina. The vaginal applicator 81 is particularlyuseful in conjunction with the device 50 as depicted in FIG. 10. Also,the vaginal applicator 81 is particularly well suited for use when thecopper ion treatments are in the form of either lotion, cream or gel.The vaginal applicator 81 comprises a hollow barrel 83 and a plunger 85slidably mounted in the hollow barrel 83. The barrel 83 has an openforward end defining a discharge openings 89 and has a rearward end wallthrough which a stem 91 of the plunger passes. The stem 91 is attachedat one end thereof to an internal flange 93 disposed within the barrelin close, sealing relation therewith. The plunger has a finger flange 95attached to an opposite end of the stem 91 that is disposed external ofthe barrel 83, the flange 95 being engageable with a finger or fingersof a hand in order to selectively depress and withdraw the plunger 85relative to the barrel 83. For use with the device 50, the forward endof the barrel 83 is provided with an internal thread 97 to threadedlyengage with the external thread 55 on the neck 56 of the tube 52.

FIG. 10 illustrates the vaginal applicator 81 being filled with thecooper ion treatment from the tube 52 of the device 50. As seen in FIG.10, the cap 54 is removed from the neck 56 of the tube 52, and theforward end of the barrel 83 is threaded onto the neck 58 via threadedengagement of the threads 55 and 97. At this stage, the plunger 85 isfully withdrawn relative to the barrel 83 such that the internal flange93 is in abutment with the rearward end wall of the barrel 83. The tube52 is then squeezed using pressure from the fingers in order to dispensethe copper ion treatment, represented at 98, into the barrel 83 from theopen neck 56 of the tube 52. When the barrel 83 is sized for aparticular dosage of copper ion treatment, a sufficient amount of copperion treatment can be dispensed from the tube 62 to entirely fill thespace within the barrel 83 from the neck of the tube 56 to the internalflange 93 which is in abutment with the rearward end wall of the barrel.Alternatively, an indicia or other marking 99 can be provided on thebarrel 83 to indicate the point to which the barrel 83 should be filledwith copper ion treatment 98 from the tube 52. It is preferred thatfilling the space within the barrel from the neck of the tube to theinternal flange corresponds to a dose of 5 grams of the copper iontreatment. Once the barrel 83 has been filled with the appropriateamount of copper ion treatment 98, the barrel 83 is disengaged from theneck 56 of the tube 52 by disengaging the thread 97 from the thread 55.In order to dispense the copper ion treatment 98 from the applicator 81,the finger flange 95 of the plunger 85 is depressed toward the barrel 83using a finger, thereby causing the internal flange 93 to push thecopper ion treatment 98 through the discharge opening 89 as the plunger85 is depressed relative to the barrel 83. When the finger flange 95meets the rearward end wall of the barrel 83, the copper ion treatment98 will be fully discharged from the applicator. It should beappreciated that the applicator 81 could be used in conjunction withother devices for supplying the copper ion treatments to the barrel 85.It should also be appreciated that the applicator 81 can be supplied foruse pre-filled with copper ion treatment 98, in which case the forwardend of the barrel would be provided with, a removable cap or seal. Theapplicator 81 is particularly advantageous for supplying the copper iontreatments to the vagina. Accordingly, prior to depressing the plunger85 to discharge the copper ion treatment 98 from the barrel 83, theforward end of the barrel 83 would be introduced into the vagina untilthe rearward end of the barrel was located near the entrance to thevagina. Then, upon depressing the plunger 85, the copper ion treatment98 is discharged from the discharge opening 89 into the vagina.

Another type of applicator useful in applying the copper ion treatmentsto anatomical tissue is shown at 101 in FIG. 11. The applicator 101 isin the nature of a swab comprising a handle 103 and a body of absorbentmaterial 105 at are end of the handle 101. The applicator 101 can beused in conjunction with a container or bottle containing a copper iontreatment, such as the device 40 of FIG. 4. Upon removal of the cap 44from the bottle 42 of the device 40, the handle 103 of the applicator101 can be grasped with a hand used to manipulate the applicator 101 inorder to dip the body of absorbent material 105 into the copper iontreatment within the bottle 42. The body of absorbent material 105 canthen be gently contacted with anatomical tissue to be treated therebycausing the copper on treatment carried by the absorbent body 105 to bedeposited on the anatomical tissue to be treated. The applicator 101 isbest suited for applying copper ion treatments to localized areas of theskin, nails, ear canal, nostrils, mouth and throat. Of course, it shouldbe appreciated that swab applicators 101 can be provided in sealedpackages with the bodies of absorbent material 105 pre-supplied withcopper ion treatment.

Another type of earner that can be used to deliver copper ion treatmentsto the vagina is a tampon. The tampon used can be a commerciallyavailable tampon or one similar thereto. The tampon can be one having anapplicator including a barrel containing the absorbent tampon body and aplunger slidable within the barrel to dispose or eject the absorbenttampon body from an open forward and of the barrel once the forward endhas been introduced in the vagina an appropriate distance in a commonlyknown manner of tampon use. In this case, an appropriate amount ofcopper ion treatment can be supplied to the absorbent tampon body viathe open forward end of the barrel prior to introduction of theapplicator the vagina and ejection of the absorbent tampon body from theapplicator into the vagina. Another suitable tampon can be one withoutan applicator, i.e. a digital tampon, where the absorbent tampon body isinserted in the vagina by pushing it with the fingers. In this case, theappropriate amount of copper ion treatment is simply deposited on theabsorbent tampon body prior to its insertion in the vagina. In bothcases, unless the tampon is going to be inserted in the vaginaimmediately or soon after the absorbent tampon body has been providedwith the appropriate mount of copper ion treatment, the tampon should bestored in a sealed container or package until the time of its use inorder to avoid evaporation of the copper ion treatment. It should beappreciated that tampon bodies to which the copper ion treatment hasbeen supplied can be provided in sealed containers or packages, with orwithout an applicator, as a ready-to-use commercial product.Alternatively, the appropriate amount of copper ion treatment may bedeposited by the user on the absorbent tampon bodies of tampons soldseparately or in injunction with the copper ion treatment. Preferably,the tampon bodies are supplied with an amount of popper ion-containingsolution in the range of 6 to 10 milliliters.

FIG. 12 illustrates a tampon 110 according to an aspect of the presentinvention including an applicator 111 having a hollow barrel 113 and ahollow plunger 115, and an absorbent tampon body 118, to which theappropriate amount of copper ion treatment has been supplied, disposedin the barrel 113 with the string 120 of the tampon body extending froma rear end of the plunger 115. The plunger 115 is slidable within andtoward the barrel 113 to push the tampon body 118 and eject it from anopen forward end 128 of the barrel. The forward end 128 of the barrel113 can be tapered to facilitate introduction and advancement in thevagina and can be provided with slits that expand as the tampon body 118passes therethrough. The tampon 110 is provided in an air-tightcontainer or bottle 122 having a removable cap or lid 124. In order touse the tampon 110, the lid 124 is removed from the bottle 122 and thetampon 110 is removed from the bottle. The tampon 110 is inserted in thevagina in a conventional manner of using tampons. More specifically, theapplicator 111 is held by grasping a finger grip 126 on the barrel 113,and the forward end 128 of the barrel is inserted in the vagina. Theapplicator 111 is advanced into the vagina until the fingers graspingthe finger grip 126 touch the entrance to the vagina. The plunger 115 isthen pushed into the barrel 113, thus causing the tampon body 118 to beejected from the forward end 128 of the barrel into the vagina. Theapplicator 111 is then withdrawn from the vagina and discarded, leavingthe tampon body 118 in place in the vagina. Once the tampon body 118 isin place in the vagina, the copper to treatment carried by the tamponbody contacts the anatomical tissue of the vagina and leaks into thevaginal fluid normally present in the vagina. The tampon body 118 isremoved from the vagina at the appropriate time by grasping and pullingon the string 120. Examples of tampons according to an aspect of theinvention are described below in Examples 23 and 24.

EXAMPLE 23

A tampon for delivering a copper ion treatment to the vagina is preparedby supplying 5 milliliters of a copper ion-containing solution to anabsorbent tampon body intended to be it into the vagina.

EXAMPLE 24

A tampon for delivering a copper ion treatment to the vagina is preparedby supplying 10 milliliters of a copper ion-containing solution to anabsorbent tampon body intended to be introduced into the vagina.

The copper ion-containing solution used in Examples 23 and 24 is thecopper ion-containing solution in its original form as obtained inaccordance with the method set forth in Example 1. However, it should beappreciated that tampons can be provided in which the tampon bodies aresupplied with the alternative copper ion-containing solutions or otherforms of the copper ion treatments.

Another type of came useful to deliver the copper ion treatments to thevagina and rectum is a suppository. Suppositories are commonly used inthe vagina and rectum (anus) as a means for dispensing various activeingredients or medicaments. Suppositories are made in various shapesincluding oviform, globular, conical and bullet shapes, and in varioussizes. Suppositories typically weigh in the range of 1 to 5 grams.Suppositories can be solid bodies composed of a mixture of a suitablesuppository base material and the active ingredients or medicaments.Alternatively, suppositories can be made with a solid outer wall ofsuppository base material enclosing non-solid active ingredients ormedicaments. The suppository base materials used in suppositories allowthem to dissolve or melt when exposed to the moisture (body fluid) orheat (body temperature) found in the vagina or rectum (rectal or analcanal), thereby releasing the active ingredients or medicaments into thevagina or rectum. Suitable suppository base materials in dude oleaginous(fatty) base materials, including was butter, theobroma oil andsynthetic triglycerides, or water soluble or miscible base materials,including glycerinated gelatin and polyethylene glycol (PEG) polymers.It is preferred that the base materials be non-toxic, non-initiating,inert, and biocompatible. Suppositories suitable for use in an aspect ofthe present invention can be prepared in various ways according toconventional methods for preparing suppositories including compressionmolding and fusion molding. Suppositories for use as vaginal and rectalsuppositories according to an aspect of the present invention arepreferably made in two different sizes, i.e. a suppository weighing 3grams and a suppository weighing 5 grams, to accommodate different sizesof vaginal and rectal anatomy. Each size suppository can be made indifferent strengths based on the percentage by weight of the activeingredient, i.e. the copper ion treatment, relative to the total weightof the suppository. Preferably, the amount of copper ion-containingsolution in the suppository is in the range of 5% to 30% of the totalweight of the suppository. The suppositories are preferably formed inplastic molds and can be stored at room temperature. The suppositorieswill be effective against the body condition being treated when the onlyactive ingredient contained in the vaginal end rectal suppositories isthe copper ion treatment. However, the vaginal and rectal suppositoriescould contain additional in that are inactive with respect to theunderlying condition or conditions being treated, such as preservatives,penetrating additives, bioadhesives and stability aids. Thesuppositories may be inserted in the vagina and rectum using thefingers, or the suppositories may be provided with applicators tofacilitate insertion thereof in the vagina and rectum. Examples ofvaginal and rectal suppositories according to an aspect of the inventionare set forth in Examples 25-32, which utilize the copper ion-containingsolution of Example 1. However, the alternative copper ion-containingsolutions could be used in Examples 25-32.

EXAMPLE 25

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 5 percent of the total weightof the suppository.

EXAMPLE 26

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 10 percent of the totalweight of the suppository.

EXAMPLE 27

A suppository base material is combined with an appropriate mount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 20 percent of the totalweight of the suppository.

EXAMPLE 28

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 30 percent of the totalweight of the suppository.

EXAMPLE 29

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 5 percent of the total weightof the suppository.

EXAMPLE 30

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 10 percent of the tot weightof the suppository.

EXAMPLE 31

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 6 grams, wherein thecopper ion-containing solution constitutes 20 percent of the total eightof the suppository.

EXAMPLE 12

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 30 percent of the totalweight of the suppository.

FIG. 13 illustrates a strip 131 of interconnected packages or pods 132,each enclosing a vaginal or rectal suppository 130 containing a copperion treatment. The pods 132 are separated from each other by aperforation line 133 allowing the pods 132 to be detached from eachother by tearing along the perforation tines 133 as depicted in FIG. 13.Each pod 132 has front and rear walls 135 between which a suppository130 is retained. The front and rear walls 135 are sealed to, one anotheralong their peripheral edges. As shown in FIG. 14, each pod 132 isprovided with a pair of finger tabs 134 respectively attached to thefront and rear walls 135, the finger tabs 134 being capable of beingpulled in opposite directions using the fingers to separate the opposedwalls 135 and thereby release the suppository 130 contained therein.

FIG. 15 illustrates an applicator 181 suitable for use in delivering asuppository 130 to the vagina or rectum. The applicator 181 is similarto the applicator 81 but does not have an internal thread at the forwardend of the bare 183. In addition, the plunger 185 of the applicator 181has two internal flanges 193 a and 193 b within the barrel 183, theflange 193 a controlling the distance that the plunger can be withdrawnrelative to the barrel and the flange 193 b serving to eject thesuppository from the barrel when the plunger is depressed the fullamount. In use, a suppository 130 is manually positioned in the openforward end of the barrel 183 as illustrated in FIG. 15. The openforward end of the barrel 183 is preferably sized to retain thesuppository 130 in position without being overly snug or tight. Theplunger 185 is withdrawn the full amount relative to the barrel 183,which coincides with abutment of internal flange 193 a with the rearwardend wall of the barrel 183. The forward end of the barrel 183 holdingthe suppository is then introduced in the vagina or rectal (anal) canal,and the applicator 181 is gently pushed into the vagina or rectal canaluntil the fingers holding the rearward end of the barrel 183 areadjacent or touch the entrance to the vagina or rectal canal. The fingerflange 195 is then depressed to push the plunger 185 toward and into thebarrel 183 as shown by the arrow in FIG. 15, thus causing the flange 193b to engage the suppository 130 and eject it from the forward end of thebarrel into the vagina or rectal canal. The applicator 181 is thenremoved from the vain or rectal canal, leaving the suppository in thevagina or rectal canal. The suppository will melt or dissolve in thevagina or rectal canal such that the copper ion treatment is released tocontact anatomical tissue of the vagina or rectal canal and to minglewith body fluid present in the vagina or rectal canal.

Another type of carrier that can be used to deliver the copper iontreatments to anatomical tissue is a body wipe. FIG. 16 illustrates abody wipe 200 contained in a sealed package 202 having front and rearwalls 203. The body wipe 200 comprises thin sheet of material disposed afolded condition when retained between the front and rear walls 203,which are sealed along their peripheral edges. The body wipe 200enclosed between the front and rear walls 203 contains a wet or moistcopper ion treatment. The front and rear walls 203 may be grasped by thefingers at corresponding corners thereof and pulled in oppositedirections similar to the pods 132 in order to separate the front andrear wells 203 and thereby allow the body wipe 200 to be removed fromthe package 202. FIG. 16 shows the package 202 in a partially opencondition in which corresponding corner sections of the front and rearwails 203 have been peeled away from one another thereby providingaccess to the body wipe 200. Upon removal from the package 202, the bodywipe 200 can be unfolded to its full size, which is substantially largerthan its size in the folded condition, and can be used to wipeanatomical tissue to be treated causing the copper ion treatment to betransferred to the anatomical tissue. The body wipe 200 is advantageousfor applying the copper ion treatments to the skin and the externalgenital and rectal areas.

Another type of carrier for the copper ion treatments is a wounddressing, such as a band aid, gauze pad or similar device. Such carrierscan be selected from products that are commercially available forremovable application to the skin to temporarily cover and protect anaffected area of the skin. FIG. 17 depicts a carrier in the nature of awound dressing 300 having a surface 301 for being placed in contact withthe skin. The surface 301 includes a protective surface 302 for beingpositioned over a wound, and an adhesive border surrounding the surface302. In use, a copper ion treatment, such as the copper ion-containingsolution in original form, can be liberally sprayed onto the surface 302of the carrier that is applied adjacent or in contact with the skin.Then, when the surface 302 of the carrier is applied adjacent or incontact with the skin and the carrier is left in place on the skin for aperiod of time, the copper ions contact or are transferred to the skinand provide the therapeutic effects described above. Of course, it wouldbe possible to provide carriers of this type in sealed packages in whichthe carriers are pre-supplied or pre-treated with the copper iontreatment similar to the body wipe 200.

A further type of carrier for the copper ion treatments is a skin patch,such as a dermal patch or a transdermal patch, represented at 400 inFIG. 18. The skin patch 400 has a drug delivery surface 401 containingthe copper ion treatment surrounded by an adhesive border 402. The patchis applied to the skin and left in place for a period of time with thedrug delivery surface in contact with the skin, causing the copper ionsto diffuse through the skin where they can act locally or penetrate thecapillaries for broader systemic effects. Examples of suitabletransdermal patches are the transdermal and microneedle 3M Drug DeliverySystems manufactured by 3M Corporation.

An additional type of owner for the copper ion treatments is suturematerial, represented at 500 in FIG. 19, used by medical professionalsto close or suture external or internal incisions or wounds, i.e.“stitches.” Prior to using the suture material 500, which can beconventional suture material, the suture material can be soaked in thecopper ion-containing solution for a period of time in order to cover orsaturate the suture material with the solution. Suture material can alsobe stored in sealed packages containing the copper ion-containingsolution. Then, when the suture material 500 is used to create suturesor stitches in anatomical tissue T as seen FIG. 19, the copper ions inthe solution contact the anatomical tissue and provide the therapeuticeffects previously described.

The copper ion-containing solution and the other forms of copper iontreatments described herein can be used on anatomical tissue in variousareas of the body including the genital-rectal areas (vagina, vulva,penis, scrotum, rectum (anus), rectal (anal) canal and surroundinganatomical areas), the oral-respiratory-otic areas (mouth, throat,airway, nostrils and ears) and the dermatological areas (skin and nails)of the body. The treatment effects provided by the copper ion treatmentsencompass treatment of active or existing disease and other undesirablebody conditions as well as the prevention of such diseases andconditions. The copper on treatments are especially beneficial for theirability to kill or neutralize harmful or undesired pathogens andmicrobes including bacteria, viruses and fungi. Although the copper ontreatments are applied to to anatomical tissue and have a for effect ondiseases and undesirable body conditions affecting the anatomicaltissue, the copper ion treatments also have a broader systemic effect ondiseases and undesirable body conditions. The effects realized with thecopper ion treatments include antibacterial, antimicrobial, antiseptic,antifungal, antiviral, anti-pathogenic, anti-inflammatory, spermicidal,neutralization of free radicals, promotion of healing and tissue repair,prevention of and immuno-boosting effects. The diseases or conditionsaffecting the genital-rectal areas that are treatable with the copperion treatments include vaginitis, bacterial vaginosis, hemorrhoids,vaginal dryness, imbalances in vaginal pH, bacterial infections causedby gonorrhea, chlamydia, streptococcus and staphylococcus, protozoaninfections caused by trichomonas, pelvic inflammatory disease, viralinfections caused by herpes (I and II), HPV and HIV, fungal infectionscaused by yeast, candida, thrush and other fungi, exposure to sexuallytransmitted diseases, and the risk of undesired pregnancy(contraception). The diseases or conditions affecting theoral-respiratory-otic areas that are treatable with the copper iontreatments include bacterial infections caused by gonorrhea, chlamydia,streptococcus and staphylococcus, protozoan infections caused bytrichomonas, viral infections caused by herpes (I and II), HPV and HIV,canker sores, mouth sores, mouth ulcers, colds, sinusitis,rhinosinusitis, sore throat, nasal discharge, congestion, runny nose,bronchitis, allergies, asthma, tonsillitis, wheezing, sneezing, earinfections, earache, pressure in the ears, cough, hoarseness,laryngitis, sore gums, periodontal disease, bad breath and tooth decay.The diseases or conditions affecting the dermatological areas that aretreatable with the copper ion treatments include bacterial infectionscaused by staphylococcus, streptococcus, enterobacter, E. coli andpseudomonas, viral infections caused by shingles, herpes (I and II) andHPV, fungal infections such as athlete's foot, ringworm and toenailfungus, impetigo, rosacea, psoriasis, eczema, warts, sun/wind damage,dry skin, age spots, pigmentation, scarring, blisters, boils, cysts,pimples, cuts, scratches, burns, abrasions, splinters, insect bites andstings, animal bites and scratches, ulcers, loss of elasticity orcollagen, wrinkles, sagging skin, acne, measles, chicken pox, and thepresence of pathogens and microbes on the skin that is an inevitableconsequence of daily life. Based on the result of laboratory testing, itis expected that the copper ion treatments will kill bacteria causingbacterial vaginosis, gonorrhea and chlamydia, and the virusesresponsible for herpes (I and II) and HIV at a kill rate of 99.99percent in 6 hours. Accordingly, the copper ion treatments aresufficiently effective to “cure” the diseases and conditions describedherein and to prevent the occurrence or development of such diseases andconditions. Similarly, copper has been demonstrated as having thecapability to kill or render inactive staphylococcus, streptococcus,enterobacter, trichomonas, E. coli and pseudomonas. The copper iontreatments are highly effective at treating the various abnormal orundesired body conditions while being safe and non-toxic. In particular,copper toxicity is so rare that the World Health Organization (WHO) hasdetermined that there is no need for setting an upper threshold for theingestion of copper. The copper ion treatments can thus be safely usedwithout concern for overdosing or improper use. Moreover, it is believedthat, to date, no bacteria or other harmful microorganisms have beenfound to be capable of developing a resistance to copper, in contrast tothe many bacteria and organisms that have developed or are in theprocess of developing resistance to conventional antibiotics. Themulti-target effects of copper makes bacterial resistance extremelyunlikely as copper kills bacteria very quickly and leaves almost nosurvivors. Consequently, them is neither the time for bacteria to learnhow to resist the killing effect of copper or the possibility to pass onany knowledge to a significant population of survivors. The copper iontreatments provide a degree of efficacy and safety for treating a widearray of diseases and body conditions that far surpasses conventionalpharmaceutical and non-pharmaceutical products and drugs available fortreating the same conditions.

Inasmuch as the present invention is subject to many variations,modifications and changes in detail it is intended that all subjectmatter discussed above or shown in the accompanying drawings beinterpreted as illustrative only and not be taken in a limiting sense.

1.-31. (canceled)
 32. A copper-ion containing suspension consisting of:(a) a solution consisting of water and sodium chloride; (b) one or moreof acetic acid and sodium acetate disposed in the solution; and (c)copper ions from a copper alloy disposed in the solution, the copperions constituting between about 0.0002% and about 0.00627% of the copperion-containing suspension by weight, wherein the copper ion-containingsuspension has a pH of 5±0.4, and wherein the copper ions are leachedinto the solution by a process consisting of: i. placing the copperalloy into the solution; ii. allowing the copper alloy to remain in thesolution for a predetermined period of time; and iii. removing thecopper alloy from the solution after the copper ions have leached fromthe copper alloy into the solution.
 33. A copper ion cream consisting ofthe copper ion-containing suspension recited in claim 32 and a creambase.
 34. The copper ion cream recited in claim 33 wherein thepercentage of copper ion-containing suspension relative to the totalweight of the copper ion cream is between 5 percent and 30 percent. 35.The copper ion cream recited in claim 34 wherein the percentage ofcopper ion-containing suspension relative to the total weight of thecopper ion cream is between 5 percent and 10 percent.
 36. The copper ioncream recited in claim 34 wherein the percentage of copperion-containing suspension relative to the total weight of the copper ioncream is between 10 percent and 20 percent.
 37. The copper ion creamrecited in claim 34 wherein the percentage of copper ion-containingsuspension relative to the total weight of the copper ion cream isbetween 20 percent and 30 percent.
 38. A copper ion lotion consisting ofthe copper ion-containing suspension recited in claim 32 and a lotionbase.
 39. The copper ion lotion recited in claim 38 wherein differentstrengths of the copper ion lotion are provided based on the percentageof the copper ion-containing suspension relative to the total weight ofthe copper ion lotion.
 40. The copper ion lotion recited in claim 39wherein the copper ion lotion contains at least 5 percent of the copperion-containing suspension relative to the total weight of the copper ionlotion.
 41. A copper ion gel consisting of the copper ion-containingsuspension recited in claim 32 and a gel base.
 42. The copper ion gelrecited in claim 41 wherein different strengths of the copper ion gelare provided based on the percentage of the copper ion-containingsuspension relative to the total weight of the copper ion gel.
 43. Thecopper ion gel recited in claim 42 wherein the copper ion gel containsat least 5 percent of the copper ion-containing suspension relative tothe total weight of the copper ion gel.
 44. A copper ion foam consistingof the copper ion-containing suspension recited in claim 32 and a foambase.
 45. The copper ion foam recited in claim 44 wherein differentstrengths of the copper ion foam are provided based on the percentage ofthe copper ion-containing suspension relative to the total weight of thecopper ion foam.
 46. The copper ion foam recited in claim 45 wherein thecopper ion foam contains at least 5 percent of the copper ion-containingsuspension relative to the total weight of the copper ion foam.
 47. Awipe consisting of the copper ion-containing suspension recited in claim32 and a sheet of wiping material, wherein the copper ion-containingsuspension is applied to the sheet of wiping material.
 48. A patchconsisting of the copper ion-containing suspension recited in claim 32and a transdermal patch, wherein the copper ion-containing suspension isapplied to the transdermal patch.
 49. The patch recited in claim 48wherein said transdermal patch includes a copper ion surface configuredto deliver the copper ions of the copper ion-containing suspension. 50.The patch recited in claim 49 wherein said transdermal patch includes anadhesive border.
 51. The copper ion-containing suspension recited inclaim 32 wherein the predetermined period of time is 24 hours and thesolution is maintained at a temperature of 37° Celsius±1° C. during thepredetermined period of time.
 52. The copper ion-containing suspensionrecited in claim 32 wherein the copper alloy is selected from the groupconsisting of a brass, a bronze, a copper-nickel alloy, and acopper-nickel-zinc alloy.
 53. A method of making a copper ion-containingsuspension consisting of: (a) placing a copper alloy into a solutioncontained in a vessel, wherein the solution consists of water, sodiumchloride, and one or more of acetic acid and sodium acetate; (b)allowing the copper alloy to remain in the solution for a predeterminedperiod of time; and (c) removing the copper alloy from the solutionafter copper ions have leached from the copper alloy into the solution;wherein the copper ions constitute between about 0.0002% and about0.00627% of the copper ion-containing suspension by weight, and whereinthe copper ion-containing suspension has a pH of 5±0.4.
 54. The methodrecited in claim 53 further consisting of in step b, the vessel is putin an oven and the solution in the vessel is maintained at a temperatureof 37° Celsius±1° C. for 24 hours.
 55. The method recited in claim 53wherein in step (a) 102 grams of the copper alloy is placed into 7.44ounces of the solution.
 56. The method recited in claim 53 furtherconsisting of heating the solution to a temperature of 37° Celsius±1° C.prior to step a.
 57. The copper ion-containing suspension recited inclaim 53 wherein the copper alloy is selected from the group consistingof a brass, a bronze, a copper-nickel alloy, and a copper-nickel-zincalloy.
 58. A copper ion cream consisting of: (a) a cream base, whereinthe cream base is selected from the group consisting of: i. a cream basecomprising at least: (A) water, (B) emulsifying wax, (C) ethylhexylstearate, (D) cyclopentasiloxane, (E) sorbitol, (F) tocopheryl acetate,(G) aloe barbadensis leaf juice powder, (H) disodium EDTA, (I)methylchloroisothiazolinone, and (J) methylisothiazolinone; and ii. acream base comprising at least: (A) water, (B) white petrolatum, (C)sorbitol solution, (D) cetearyl alcohol, (E) propylene glycol, (F)ceteareth-20, (G) simethicone, (H) glyceryl monostearate, (I)polyethylene glycol monostearate, (J) sorbic acid, and (K) butylatedhydroxytoluene; and (b) a copper ion-containing suspension having a pHof 5±0.4, the copper ion-containing suspension consisting of: i. asaline solution; ii. one or more buffers disposed in the salinesolution; and iii. copper ions disposed in the saline solution, thecopper ions constituting between about 0.0002% and about 0.00627% of thecopper ion treatment by weight; and wherein the copper ions are disposedin the saline solution as a result of: 1) placing a copper alloy intothe saline solution; 2) allowing the copper alloy to remain in thesaline solution for a predetermined period of time; and 3) removing thecopper alloy from the saline solution, thereby disposing the copper ionsin the saline solution.
 59. The copper ion-containing suspension recitedin claim 58 wherein the copper alloy is selected from the groupconsisting of a brass, a bronze, a copper-nickel alloy, and acopper-nickel-zinc alloy.